Advair Safety and Black Box Warning

Is Advair Safe?

Advair, a commonly used medication to treat asthma, has been given a "black box" warning by the FDA. Daniel More, MD

What is Advair?

Advair (fluticasone/salmeterol) is an inhaled medication used to treat asthma and COPD. It is a combination medication consisting of an inhaled steroid and a long-acting form of albuterol, called Serevent (salmeterol). The combination of these medications works especially well to control the inflammation in asthma. The salmeterol does not replace the need for rescue inhalers, such as albuterol, which are still needed for the immediate relief of asthma symptoms.

What Risks are Associated with Advair?

Advair currently has a “black box” warning, which a precautionary statement given to the medication by the Food and Drug Administration. This warning has come about as a result of various studies on the safety of salmeterol. The largest study, called the SMART trial, showed a small increase in the risk of death and hospitalization asthma and breathing problems when taking salmeterol, particularly in African-American patients. For this reason, the FDA has placed a “black box” warning on salmeterol, as well as Foradil (formoterol), which works in much the same way.

The SMART trial did not study Advair, but since Advair contains salmeterol, the “black box” warning was also given to this medication. In fact, any medication that contains salmeterol or formoterol also has the same “black box” warning.

Salmeterol and formoterol are long-acting beta-agonists (LABAs) used in the treatment of moderate and severe asthma.

LABAs are not an adequate controller therapy by themselves for asthma, and can potentially cause life-threatening asthma attacks if used alone. This fact has been known for years, just as it is well-known that overuse of albuterol, or any other rescue medication, can place a person at risk for severe asthma attacks, and even death from asthma.

A person with asthma therefore should always use an inhaled steroid for treatment of their asthma when a LABA is required.

Unfortunately, the SMART trial did not address whether a particular patient was taking an inhaled steroid for their asthma, only if salmeterol was safe by itself in the treatment of asthma. Most of the patients with the most severe asthma, particularly African-American patients, were not taking an inhaled steroid when placed on the LABA. However, when the study went back and looked at the patients who were taking an inhaled steroid along with the LABA, there did not appear to be an added risk of severe asthma attacks or death from asthma, even in the African-American patients.

Should I Take Advair if I Have Asthma?

The FDA states that a LABA medication should not be used if a person with asthma is controlled on an inhaled steroid alone. If asthma is not controlled on an inhaled steroid, or the level of asthma is classified as being moderate to severe, then combination therapy including an inhaled steroid and a LABA is a good choice of therapy.

Other treatment choices include increasing the dose of the inhaled steroid or the addition of another medication such as Singulair (montelukast) or theophylline. These other medication choices may not control asthma as well as the combination of an inhaled steroid and LABA.

For most people with moderate to severe asthma, or those whose asthma is not controlled on an inhaled steroid alone, the benefits of a LABA medication outweigh the risks. However, it is important for a person to know the risks and benefits of taking any medication, particularly those with a “black box” warning.

See the FDA warning letters on medications containing LABAs.

Want to keep learning? Find out more about the treatments for asthma.


Aaronson DW. The “Black Box” Warning and Allergy Drugs. J Allergy Clin Immunol. 2006;117:40-4.

Nelson HS, Weiss ST, Bleeker ER, et al. The Salmeterol Multicenter Asthma Research Trial. Chest. 2006;129:15-26.

Nelson HS. Long-Acting Beta-Agonists in Adult Asthma: Evidence that these Drugs are Safe. Primary Respiratory Care Journal. 2006;15:271-77.

Continue Reading